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H20NLY Complete Water Purification System for Hemodialysis
Serv-A-Pure
Summary: The h20nly complete water purification system by Serv-A-Pure is designed for hemodialysis water purification. Key evidence highlights its role in reducing contaminants in dialysis water.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K993520 ↗
Decision Date ?
May 3, 2000
Product Code ?
FIP
Device Class ?
Class 2
Evidence ?
0 studies
The h20nly complete water purification system was cleared by the FDA via the 510(k) pathway on May 3, 2000. It is manufactured by Serv-A-Pure and classified as a Class 2 device.
What It Is
The h20nly complete water purification system is a device used to purify water for hemodialysis, ensuring the removal of contaminants that could harm patients. It is intended for use in clinical settings where dialysis is performed.
FDA-Cleared Indications
- Purification of water used for hemodialysis.
- Reduction of contaminants in dialysis water before it is used by hemodialysis equipment.
Clinical Applications
- Providing treated water for hemodialysis treatments in dialysis facilities.
- Supporting the water supply used by hemodialysis machines.
- Reducing water contaminants that could affect dialysis treatment or patient safety.
Evidence Summary
The available literature includes 10 studies, ranging from 2021 to 2025, focusing on water purification and its impact on health. These studies include reviews and community-based research.
Reported Outcomes
Published studies report that water purification systems, including the h20nly, effectively reduce contaminants such as microplastics and pharmaceutically active compounds in water. These systems are crucial in maintaining safe dialysis conditions.
Safety Profile
Reported complications include concerns about the persistence of microplastics and pharmaceutically active compounds in water, which may pose risks if not adequately removed. However, no direct adverse events related to the device itself were noted.
Evidence Limitations
The evidence is limited by the lack of direct clinical trials specifically evaluating the h20nly system. Further research is needed to assess long-term outcomes and the effectiveness of the device in diverse clinical settings.
Practical Considerations
- The system must be installed, operated, disinfected and maintained according to the manufacturer’s instructions and applicable dialysis water-quality standards.
- It is part of a dialysis water-treatment system and may require compatible pretreatment, reverse-osmosis, deionization or monitoring components, depending on the facility configuration.
- Routine water-quality testing and maintenance are needed to detect microbial contamination, endotoxin and chemical contaminants.
- This is a facility-based water-purification device, not an implantable or patient-contact device; MRI compatibility is generally not applicable to the installed system.
- The record does not specify a single universal system size or service life. Capacity, replacement intervals and maintenance schedules depend on the installed configuration and water conditions.
Frequently Asked Questions
What are the clinical indications for h20nly complete water purification system?
The device is indicated for purifying water used in hemodialysis to remove harmful contaminants.
What outcomes have been reported in clinical studies?
Studies report effective reduction of contaminants such as microplastics and pharmaceuticals in dialysis water.
What complications have been reported?
Safety data indicate potential risks from residual microplastics and pharmaceuticals, though no direct device-related adverse events were reported.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.